83 FR 30081 - Removing Outmoded Regulations Regarding the Ricky Ray Hemophilia Relief Fund Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 124 (June 27, 2018)

Page Range		30081-30082
FR Document		2018-13836

This action removes the outmoded regulations for the Ricky Ray Hemophilia Relief Fund Program. The program and its implementing regulation have been rendered obsolete by the statutory language in the authorizing legislation stating that the Fund should terminate on the expiration of the 5-year period beginning on the date of the enactment of the Act. The statute was enacted on November 12, 1998; thus, the fund expired on November 12, 2003.

Federal Register, Volume 83 Issue 124 (Wednesday, June 27, 2018)

[Federal Register Volume 83, Number 124 (Wednesday, June 27, 2018)]
[Rules and Regulations]
[Pages 30081-30082]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13836]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 130

RIN 0906-AB13


Removing Outmoded Regulations Regarding the Ricky Ray Hemophilia 
Relief Fund Program

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This action removes the outmoded regulations for the Ricky Ray 
Hemophilia Relief Fund Program. The program and its implementing 
regulation have been rendered obsolete by the statutory language in the 
authorizing legislation stating that the Fund should terminate on the 
expiration of the 5-year period beginning on the date of the enactment 
of the Act. The statute was enacted on November 12, 1998; thus, the 
fund expired on November 12, 2003.

DATES: This action is effective July 27, 2018.

FOR FURTHER INFORMATION CONTACT: Sweta Maheshwari J.D., Legislative 
Analyst, Division of Policy and Shortage Designation, Bureau of Health 
Workforce, HRSA, 5600 Fishers Lane, Room 11W21A, Rockville, MD 20857, 
by phone at (301) 945-3527, or by email at [email protected].

SUPPLEMENTARY INFORMATION: In response to Executive Order 13563, Sec. 
6(a), which urges agencies to repeal existing regulations that are 
outmoded from the Code of Federal Regulations (CFR), HHS is removing 42 
CFR part 130. HHS believes that there is good cause to bypass notice 
and comment and proceed to a final rule, pursuant to 5 U.S.C. 
553(b)(3)(B). The action is non-controversial, as it merely removes a 
provision from the CFR that is obsolete. This rule poses no new 
substantive requirements on the public.

Background

    The Ricky Ray Hemophilia Relief Fund Act of 1998 (Pub. L. 105-369) 
established the Ricky Ray Hemophilia Relief Fund Program designed to 
provide payments to individuals with blood-clotting disorders, such as 
hemophilia, who contracted HIV through the use of antihemophilic factor 
administered between July 1, 1982, and December 31, 1987. The Act also 
provided for payments to certain persons who contracted HIV from an 
individual as described above and certain specified survivors.
    HHS promulgated 42 CFR part 130 to establish the proper regulatory 
framework for program implementation. The regulation can be 
conceptualized as four parts: The process for payment, the 
documentation required to prove eligibility, the petition process, and 
the reconsideration process. The Ricky Ray Hemophilia Relief Fund was 
authorized with a directive to pay $100,000 in compensation to eligible 
individuals. At that time, however, no funds were appropriated to 
implement this statute. In FY 2000, Congress appropriated $75 million 
and, in FY 2001, Congress appropriated $580 million, for a total of 
$655 million. The appropriated amounts provided sufficient funding to 
make compassionate payments on all eligible petitions received by the 
program. The program received over 6,000 petitions resulting in 
approved payments over $550 million.
    The statutory language in the authorizing legislation stated that 
the ``Fund shall terminate upon the expiration of the 5-year period 
beginning on the date of the enactment of this Act.'' The statute was 
enacted on November 12, 1998; thus, the fund expired on November 12, 
2003. The program is no longer in effect or funded. The repeal of this 
regulation should not create any challenges for other programs, as the 
regulation was strictly for the implementation of the Ricky Ray 
Hemophilia Relief Fund program, which has not been in operation for 
almost 14 years.

Executive Orders 12866, 13563, 13771, and 13777

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13771 directs agencies to categorize all impacts which generate 
or alleviate costs associated with regulatory burden and to determine 
the actions net incremnatal effect.

[[Page 30082]]

    Section 3(f) of Executive Order 12866 defines a ``significant 
regulatory action'' as an action that is likely to result in a rule: 
(1) Having an annual effect on the economy of $100 million or more in 
any 1 year, or adversely and materially affecting a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local or Tribal governments or communities 
(also referred to as ``economically significant''); (2) creating a 
serious inconsistency or otherwise interfering with an action taken or 
planned by another agency; (3) materially altering the budgetary 
impacts of entitlement grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) raising novel 
legal or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects ($100 million or more in any 1 
year). HHS submits that this final rule is not ``economically 
significant'' as measured by the $100 million threshold, and hence not 
a major rule under the Congressional Review Act. This rule has not been 
designated as a ``significant regulatory action'' under Executive Order 
12866. Accordingly, this rule has not been reviewed by the Office of 
Management and Budget (OMB).
    Executive Order 13771, titled ``Reducing Regulation and Controlling 
Regulatory Costs,'' was issued on January 30, 2017. HHS identifies this 
final rule as a deregulatory action (removing an obsolete rule from the 
Code of Federal Regulations). For the purposes of Executive Order 
13771, this final rule is not a substantive rule; rather it is 
administrative in nature and provides no cost savings.
    Executive Order 13777, titled ``Enforcing the Regulatory Reform 
Agenda,'' was issued on February 24, 2017. As required by Section 3 of 
this Executive Order, HHS established a Regulatory Reform Task Force 
(HHS Task Force). Pursuant to Section 3(d)(ii), the HHS Task Force 
evaluated this rulemaking and determined that these regulations are 
``outdated, unnecessary, or ineffective.'' Following this finding, the 
HHS Task Force advised the HRSA Administrator to initiate this 
rulemaking to remove the obsolete regulations from the Code of Federal 
Regulations.

Regulatory Flexibility Act

    This action will not have a significant economic impact on a 
substantial number of small entities. Therefore, the regulatory 
flexibility analysis provided for under the Regulatory Flexibility Act 
is not required.

Paperwork Reduction Act

    This action does not affect any information collections.

    Dated: June 4, 2018.
George Sigounas,
Administrator, Health Resources and Services Administration.
    Approved: June 21, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.

List of Subjects in 42 CFR Part 130

    Health care, Hemophilia, HIV/AIDS.

PART 130--[REMOVED]

0
For reasons set out in the preamble, and under the authority at 5 
U.S.C. 301, HHS amends 42 CFR chapter I by removing part 130.

[FR Doc. 2018-13836 Filed 6-26-18; 8:45 am]
BILLING CODE 4165-15-P

Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Rules and Regulations 30081

Congressional Review Act. This rule has 1345 (42 U.S.C. 254f et seq.), 95 Stat. 912 (42 Relief Fund Program designed to
not been designated as a ‘‘significant U.S.C. 254p(c)), 95 Stat. 910 (42 U.S.C. provide payments to individuals with
regulatory action’’ under Executive 254n(e)(1)). blood-clotting disorders, such as
Order 12866. Accordingly, this rule has hemophilia, who contracted HIV
Subparts B and C [Removed]
not been reviewed by the Office of through the use of antihemophilic factor
Management and Budget (OMB). ■ 2. Remove subpart B, consisting of administered between July 1, 1982, and
Executive Order 13771, titled §§ 23.21 through 23.35, and subpart C, December 31, 1987. The Act also
‘‘Reducing Regulation and Controlling consisting of § 23.41. provided for payments to certain
Regulatory Costs,’’ was issued on persons who contracted HIV from an
[FR Doc. 2018–13837 Filed 6–26–18; 8:45 am]
January 30, 2017. HHS identifies this individual as described above and
BILLING CODE 4165–15–P
final rule as a deregulatory action certain specified survivors.
(removing an obsolete rule from the HHS promulgated 42 CFR part 130 to
Code of Federal Regulations). For the DEPARTMENT OF HEALTH AND establish the proper regulatory
purposes of Executive Order 13771, this HUMAN SERVICES framework for program implementation.
final rule is not a substantive rule; The regulation can be conceptualized as
rather it is administrative in nature and 42 CFR Part 130 four parts: The process for payment, the
provides no cost savings. documentation required to prove
Executive Order 13777, titled RIN 0906–AB13
eligibility, the petition process, and the
‘‘Enforcing the Regulatory Reform reconsideration process. The Ricky Ray
Removing Outmoded Regulations
Agenda,’’ was issued on February 24, Hemophilia Relief Fund was authorized
Regarding the Ricky Ray Hemophilia
2017. As required by Section 3 of this with a directive to pay $100,000 in
Relief Fund Program
Executive Order, HHS established a compensation to eligible individuals. At
Regulatory Reform Task Force (HHS AGENCY: Health Resources and Services that time, however, no funds were
Task Force). Pursuant to Section 3(d)(ii), Administration, HHS. appropriated to implement this statute.
the HHS Task Force evaluated this ACTION: Final rule. In FY 2000, Congress appropriated $75
rulemaking and determined that these million and, in FY 2001, Congress
regulations are ‘‘outdated, unnecessary, SUMMARY: This action removes the appropriated $580 million, for a total of
or ineffective.’’ Following this finding, outmoded regulations for the Ricky Ray $655 million. The appropriated amounts
the HHS Task Force advised the HRSA Hemophilia Relief Fund Program. The provided sufficient funding to make
Administrator to initiate this program and its implementing compassionate payments on all eligible
rulemaking to remove the obsolete regulation have been rendered obsolete petitions received by the program. The
regulations from the Code of Federal by the statutory language in the program received over 6,000 petitions
Regulations. authorizing legislation stating that the resulting in approved payments over
Fund should terminate on the $550 million.
Regulatory Flexibility Act expiration of the 5-year period The statutory language in the
This action will not have a significant beginning on the date of the enactment authorizing legislation stated that the
economic impact on a substantial of the Act. The statute was enacted on ‘‘Fund shall terminate upon the
number of small entities. Therefore, the November 12, 1998; thus, the fund expiration of the 5-year period
regulatory flexibility analysis provided expired on November 12, 2003. beginning on the date of the enactment
for under the Regulatory Flexibility Act DATES: This action is effective July 27, of this Act.’’ The statute was enacted on
is not required. 2018. November 12, 1998; thus, the fund
Paperwork Reduction Act FOR FURTHER INFORMATION CONTACT: expired on November 12, 2003. The
Sweta Maheshwari J.D., Legislative program is no longer in effect or funded.
This action does not affect any
Analyst, Division of Policy and Shortage The repeal of this regulation should not
information collections.
Designation, Bureau of Health create any challenges for other
Dated: June 4, 2018. Workforce, HRSA, 5600 Fishers Lane, programs, as the regulation was strictly
George Sigounas, Room 11W21A, Rockville, MD 20857, for the implementation of the Ricky Ray
Administrator, Health Resources and Services by phone at (301) 945–3527, or by email Hemophilia Relief Fund program, which
Administration. at smaheshwari@hrsa.gov. has not been in operation for almost 14
Approved: June 21, 2018. SUPPLEMENTARY INFORMATION: In years.
Alex M. Azar II, response to Executive Order 13563, Sec. Executive Orders 12866, 13563, 13771,
Secretary, Department of Health and Human 6(a), which urges agencies to repeal and 13777
Services. existing regulations that are outmoded
from the Code of Federal Regulations Executive Orders 12866 and 13563
List of Subjects in 42 CFR Part 23 (CFR), HHS is removing 42 CFR part direct agencies to assess all costs and
Health, Health professions. 130. HHS believes that there is good benefits of available regulatory
For reasons set out in the preamble, cause to bypass notice and comment alternatives and, if regulation is
and under the authority at 5 U.S.C. 301, and proceed to a final rule, pursuant to necessary, to select regulatory
HHS amends 42 CFR part 23 as follows: 5 U.S.C. 553(b)(3)(B). The action is non- approaches that maximize net benefits
controversial, as it merely removes a (including potential economic,
PART 23—NATIONAL HEALTH provision from the CFR that is obsolete. environmental, public health and safety
nshattuck on DSK9F9SC42PROD with RULES

SERVICE CORPS This rule poses no new substantive effects, distributive impacts, and
requirements on the public. equity). Executive Order 13771 directs
■ 1. The authority citation for part 23 agencies to categorize all impacts which
continues to read as follows: Background generate or alleviate costs associated
Authority: Secs. 333, 338E(c), and The Ricky Ray Hemophilia Relief with regulatory burden and to
338C(e)(1), Public Health Service Act. 90 Fund Act of 1998 (Pub. L. 105–369) determine the actions net incremnatal
Stat. 2272, as amended, 95 Stat. 905, 97 Stat. established the Ricky Ray Hemophilia effect.

VerDate Sep<11>2014 14:30 Jun 26, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\FR\FM\27JNR1.SGM 27JNR1

30082 Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Rules and Regulations

Section 3(f) of Executive Order 12866 regulatory flexibility analysis provided rules, which contain modified
defines a ‘‘significant regulatory action’’ for under the Regulatory Flexibility Act information collection requirements that
as an action that is likely to result in a is not required. have not yet been approved by the
rule: (1) Having an annual effect on the Office of Management and Budget
Paperwork Reduction Act
economy of $100 million or more in any (OMB) under the Paperwork Reduction
1 year, or adversely and materially This action does not affect any Act of 1995 (PRA), Public Law 104–13.
affecting a sector of the economy, information collections. The IP CTS compensation rate adopted
productivity, competition, jobs, the Dated: June 4, 2018. for the 2018–19 Fund Year shall be
environment, public health or safety, or George Sigounas, effective July 1, 2018.
State, local or Tribal governments or
Administrator, Health Resources and Services Applicability date: IP CTS providers
communities (also referred to as Administration.
‘‘economically significant’’); (2) creating must comply with the requirement to
Approved: June 21, 2018. ensure that any volume control or other
a serious inconsistency or otherwise
interfering with an action taken or Alex M. Azar II, amplification feature can be adjusted
planned by another agency; (3) Secretary, Department of Health and Human separately and independently of the
materially altering the budgetary Services. caption feature on or before December 8,
impacts of entitlement grants, user fees, List of Subjects in 42 CFR Part 130 2018.
or loan programs or the rights and FOR FURTHER INFORMATION CONTACT:
obligations of recipients thereof; or (4) Health care, Hemophilia, HIV/AIDS.
Michael Scott, Consumer and
raising novel legal or policy issues PART 130—[REMOVED] Governmental Affairs Bureau, FCC, at
arising out of legal mandates, the (202) 418–1264, or email
President’s priorities, or the principles ■ For reasons set out in the preamble, Michael.Scott@fcc.gov.
set forth in the Executive Order. and under the authority at 5 U.S.C. 301,
A regulatory impact analysis (RIA) HHS amends 42 CFR chapter I by SUPPLEMENTARY INFORMATION: This is a
must be prepared for major rules with removing part 130. summary of the Commission’s Report
economically significant effects ($100 and Order and Declaratory Ruling in CG
[FR Doc. 2018–13836 Filed 6–26–18; 8:45 am]
million or more in any 1 year). HHS Docket Nos. 03–123 and 13–24;
BILLING CODE 4165–15–P
submits that this final rule is not document FCC 18–79, adopted on June
‘‘economically significant’’ as measured 7, 2018 and released on June 8, 2018.
by the $100 million threshold, and Document FCC 18–79 concerns the
hence not a major rule under the FEDERAL COMMUNICATIONS modernization and reform of the
Congressional Review Act. This rule has COMMISSION Commission’s rules for IP CTS. The
not been designated as a ‘‘significant Commission previously sought
regulatory action’’ under Executive 47 CFR Part 64
comment on these issues in Misuse of
Order 12866. Accordingly, this rule has [CG Docket Nos. 13–24 and 03–123; FCC internet Protocol (IP) Captioned
not been reviewed by the Office of 18–79] Telephone Service;
Management and Budget (OMB). Telecommunications Relay Services and
Executive Order 13771, titled IP CTS Modernization and Reform Speech-to-Speech Services for
‘‘Reducing Regulation and Controlling Individuals with Hearing and Speech
Regulatory Costs,’’ was issued on AGENCY: Federal Communications
Commission. Difficulties, published at 78 FR 54201,
January 30, 2017. HHS identifies this September 3, 2013 (2013 IP CTS Reform
final rule as a deregulatory action ACTION: Final rule and clarification.
FNPRM). A Further Notice of Proposed
(removing an obsolete rule from the
SUMMARY: In this document, the Rulemaking (Further Notice) and Notice
Code of Federal Regulations). For the
Commission alters the methodology for of Inquiry are contained in document
purposes of Executive Order 13771, this
setting provider compensation rates for FCC 18–79 and address additional
final rule is not a substantive rule;
internet Protocol Captioned Telephone issues concerning the funding,
rather it is administrative in nature and
Service (IP CTS) and establishes interim administration, and user eligibility for
provides no cost savings.
Executive Order 13777, titled compensation rates for Fund Years this service, as well as performance
‘‘Enforcing the Regulatory Reform 2018–19 and 2019–20. The Commission goals and metrics to ensure service
Agenda,’’ was issued on February 24, also adopts rules that address the quality for users. The Further Notice
2017. As required by Section 3 of this provision of volume control on IP CTS and Notice of Inquiry will be published
Executive Order, HHS established a devices, require the accuracy of IP CTS elsewhere in the Federal Register. The
Regulatory Reform Task Force (HHS information disseminated by providers, full text of document FCC 18–79 will be
Task Force). Pursuant to Section 3(d)(ii), and prohibit the provision of service to available for public inspection and
the HHS Task Force evaluated this ineligible users. Finally, the copying via the Commission’s
rulemaking and determined that these Commission declares that speech-to-text Electronic Comment Filing System
regulations are ‘‘outdated, unnecessary, automation, without the participation of (ECFS), and during regular business
or ineffective.’’ Following this finding, a communications assistant (CA), may hours at the FCC Reference Information
the HHS Task Force advised the HRSA be used to generate IP CTS captions. Center, Portals II, 445 12th Street SW,
Administrator to initiate this DATES: Room CY–A257, Washington, DC 20554.
rulemaking to remove the obsolete Effective dates: 47 CFR 64.604(c)(10) To request materials in accessible
nshattuck on DSK9F9SC42PROD with RULES

regulations from the Code of Federal and (c)(13)(i)–(ii) are effective July 27, formats for people with disabilities
Regulations. 2018. The Commission will publish a (Braille, large print, electronic files,
document in the Federal Register audio format), send an email to fcc504@
Regulatory Flexibility Act announcing the effective date of 47 CFR fcc.gov, or call the Consumer and
This action will not have a significant 64.604(c)(11)(v) and the amendments to Governmental Affairs Bureau at (202)
economic impact on a substantial 47 CFR 64.604(c)(5)(iii)(D)(1), (6), and 418–0530 (voice), (844) 432–2272
number of small entities. Therefore, the (c)(13)(iii)–(iv) of the Commission’s (videophone), or (202) 418–0432 (TTY).

VerDate Sep<11>2014 14:30 Jun 26, 2018 Jkt 244001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\FR\FM\27JNR1.SGM 27JNR1

Document Created: 2018-11-06 09:53:13
Document Modified: 2018-11-06 09:53:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This action is effective July 27, 2018.
Contact		Sweta Maheshwari J.D., Legislative Analyst, Division of Policy and Shortage Designation, Bureau of Health Workforce, HRSA, 5600 Fishers Lane, Room 11W21A, Rockville, MD 20857, by phone at (301) 945-3527, or by email at [email protected]
FR Citation		83 FR 30081
RIN Number		0906-AB13
CFR Associated		Health Care; Hemophilia and HIV/AIDS